Shunting catheters and methods for tissual removal

Certain embodiments of the present disclosure relate to medical systems, apparatus, and methods for creating a shunt in a patient. More specifically, some embodiments of the present disclosure relate to medical systems, apparatus, and methods for creating a shunt on a cardiovascular system wall in a patient.

Heart failure is a serious condition that happens when heart cannot pump enough blood and oxygen to support other organs in the body. Heart failure is classified according to left ventricular (LV) function as “heart failure with reduced ejection fraction (EF)” (HFrEF; EF<40%), “midrange EF” (HFmrEF; EF 40-49%), or “preserved EF” (HFpEF; EF≥50%). About half of patients with heart failure have HFpEF. HFpEF generally happens when the LV and left atrial filling pressures increase significantly during exercise, with an associated increase in pulmonary pressures leading to pulmonary congestion. Structural interventions to lower elevated either left or right atrial filling pressures are gaining attention.

Studies in heart failure show that lowering left atrial pressure may reduce cardiovascular events while improving functional capacity. The creation of an interatrial shunt has emerged as a therapy to decompress the left atrium in patients with acute and chronic heart failure. As such, attention has turned toward the development of interatrial shunt devices (IASDs) as a means of reducing the detrimental increase in left-sided filling pressures with exercise in an effort to improve symptomatology. IASDs may be used to treat various kinds of heart failure and/or other diseases that may result in too high of a pressure in the right atrium of a patient.

Current IASDs reside in the interatrial septum, with risk for right-to-left shunting and systemic embolization. Moreover, preservation of the interatrial septum is important with an increasing number of left-sided transseptal transcatheter interventions. Ways to improve IASDs for safer and better procedures are needed.

According to some embodiments, a shunting catheter includes a catheter shaft including a shaft lumen and a side opening, and a tissue-removal assembly disposed in the shaft lumen in a first state and including a shunting shaft being extendable from the side opening of the catheter shaft. The shunting shaft has a curved shape when extending from the side opening to a second state, and the shunting shaft has an opening at a distal end thereof. The tissue-removal assembly includes a cutting component disposed at the distal end of the shunting shaft. In some embodiments, the cutting component can include ablation electrode(s) to deliver ablative energy. In some embodiments, the cutting component can include a mechanical coring edge (e.g., a cutting sheet).

According to some embodiments, a method of creating a shunt includes deploying a tissue-removal assembly in a shaft lumen of a catheter shaft at a first state, the tissue-removal assembly including a shunting shaft and a cutting component disposed at a distal end of the shunting shaft, operating the tissue-removal assembly to a second state, wherein the distal end of the shunting shaft extends from a side opening of the catheter shaft with a curved shape, disposing the cutting component approximate to a tissue wall of a patient, cutting, using the cutting component, the tissue wall, and removing an area of tissue from the tissue wall to form an opening in the tissue wall using the tissue-removal assembly.

While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

While the invention is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.

The following detailed description is exemplary in nature and is not intended to limit the scope, applicability, or configuration of the invention in any way. Rather, the following description provides some practical illustrations for implementing exemplary embodiments of the present invention. Examples of constructions, materials, and/or dimensions are provided for selected elements. Those skilled in the art will recognize that many of the noted examples have a variety of suitable alternatives.

Unless otherwise indicated, all numbers expressing feature sizes, amounts, and physical properties used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the foregoing specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by those skilled in the art utilizing the teachings disclosed herein. The use of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5) and any number within that range.

Although illustrative methods may be represented by one or more drawings (e.g., flow diagrams, communication flows, etc.), the drawings should not be interpreted as implying any requirement of, or particular order among or between, various steps disclosed herein. However, some embodiments may require certain steps and/or certain orders between certain steps, as may be explicitly described herein and/or as may be understood from the nature of the steps themselves (e.g., the performance of some steps may depend on the outcome of a previous step). Additionally, a “set,” “subset,” or “group” of items (e.g., inputs, algorithms, data values, etc.) may include one or more items and, similarly, a subset or subgroup of items may include one or more items. A “plurality” means more than one.

As used herein, the term “based on” is not meant to be restrictive, but rather indicates that a determination, identification, prediction, calculation, and/or the like, is performed by using, at least, the term following “based on” as an input. For example, predicting an outcome based on a particular piece of information may additionally, or alternatively, base the same determination on another piece of information. In some embodiments, the term “receive” or “receiving” means obtaining from a data repository (e.g., database), from another system or service, from another software, or from another software component in a same software. In certain embodiments, the term “access” or “accessing” means retrieving data or information, and/or generating data or information.

There are various approaches for creating an interatrial shunt, which is a connection or gateway between the left and right atria of a patient's heart for blood to flow through. In some embodiments, examples of interatrial shunt devices (IASDs) include implants or shunting catheters. For example, devices reside in the interatrial septum, with risk for right-to-left shunting and systemic embolization. In some examples, preservation of the interatrial septum is important with an increasing number of left-sided transseptal transcatheter interventions. Ways to improve IASDs for safer and better procedures are needed. At least some embodiments of the present disclosure are directed to a shunting catheter for deployment through a patient's coronary sinus (CS) for creating a shunt between the CS and the patient's left atrium (LA). In some embodiments, a shunt is formed in the patient's CS vessel by removing an area of tissue to create an opening between the patient's CS and LA. At least some embodiments of the present disclosure are directed to a shunting catheter for deployment through a patient's atrial septum (AS) for atrial septal shunting.

A patient's CS ostium may have a diameter of from about 5 mm to about 25 mm. As the CS is a relatively small vessel, at least some embodiments of the present disclosure are directed to features of a shunting catheter that helps angle a tissue-removal assembly towards a patient's vessels during deployment to remove an area of tissue to create a shunt. In some embodiments, a shunting catheter includes a catheter shaft having a distal end and a proximal end. The catheter shaft includes a shaft lumen and a side opening. In some embodiments, a tissue-removal assembly is disposed in the shaft lumen in a first state and includes a shunting shaft having a distal end being extendable from the side opening of the catheter shaft. The distal end of the shunting shaft has a curved shape when extending from the side opening to a second state. In some embodiments, the tissue-removal assembly includes a cutting component disposed at the distal end of the shunting shaft. In some embodiments, the catheter shaft is made of flexible materials that bends according to the anatomy of the CS to conform to the shape of the patient's CS. In yet some embodiments, the catheter shaft includes a stabilizing element such as distal tip that has a curve (e.g., a pre-existing curve) conforming to the shape of a patient's CS to help stabilize the catheter and minimize potential damage to a patient's tissue wall (e.g., the vessel wall of a patient's CS).

In some embodiments, an apposition element is protruded from the catheter shaft during deployment to help stabilize the catheter at a desired location for creating the shunt. In certain embodiments, the shunting shaft of the tissue-removal assembly further includes a tube (e.g., a hypotube) to support the cutting component and one or more puncture elements connected to the shunting shaft. The tube may have a plurality of cuts along the tube to help facilitate bending of the tube. In certain embodiments, the shunting catheter is inserted through the patient's superior vena cava (SVC) via a transjugular approach. In certain embodiments, the shunting catheter is inserted through the patient's inferior vena cava (IVC) via a transfemoral approach.

1 FIG. 1 FIG. 100 101 102 104 104 106 120 100 104 108 106 110 is a diagram illustrating an exemplary clinical settingfor treating a heartof the patient, using a shunting catheter system, in accordance with embodiments of the present disclosure. The shunting catheter systemincludes a shunting deviceincluding a tissue-removal assemblyconfigured to remove an area of tissue from a tissue wall. As will be appreciated by the skilled artisan, the clinical settingmay have other components and arrangements of components that are not shown in. In some embodiments, the shunting catheter systemincludes or is coupled to an imaging system (e.g., an X-ray system) which may include one or more visualization elements and a display. In some embodiments, one or more visualization elements may be disposed on the shunting device. In certain embodiments, the imaging system can help guide a physician's operation of the shunting catheterduring procedure.

106 110 112 114 112 106 112 114 110 112 110 114 112 114 112 The shunting deviceincludes a shunting catheter, a controller, and an energy source(e.g., a generator). The controlleris configured to control functional aspects of the shunting device. In embodiments, the controlleris configured to control the energy sourceto deliver energy to the shunting catheter. The controllermay be connected to the one or more visualization elements to facilitate positioning of the shunting catheterin a patient's heart during procedure. In some embodiments, the energy sourceis connected to the controller. In yet some embodiments, the energy sourcemay be incorporated into the controller.

120 110 120 110 110 120 According to some embodiments, a tissue-removal assemblycan be delivered by the shunting catheterto remove an area of tissue from a tissue wall and create a shunt. The tissue-removal assemblycan be advanceable inside a lumen of the shunting catheterand extendable from a side opening of the shunting catheterto form a curved shape. The tissue-removal assemblycan include a cutting component disposed at the distal end thereof to capture, cut, and/or collect an area of tissue from the tissue wall and create the shunt.

104 104 104 1 FIG. As will be appreciated by the skilled artisan, the depiction of the shunting catheter systemshown inis intended to provide a general overview of the various components of the shunting catheter systemand is not in any way intended to imply that the disclosure is limited to any set of components or arrangement of the components. For example, the skilled artisan will readily recognize that additional hardware components, e.g., breakout boxes, workstations, and the like, can and likely will be included in the shunting catheter system.

106 116 118 120 120 102 120 114 120 114 116 120 118 110 120 118 120 118 According to some embodiments, the shunting deviceincludes a handle, a catheter shaft, the tissue-removal assemblyconfigured to remove an area of tissue from a tissue wall. In some embodiments, the tissue-removal assemblycan include a puncture element (e.g., a puncture needle) configured to puncture through the tissue wall. In certain embodiments, the puncture element may be curved. In some instances, the puncture element may be curved or angled to bias a distal tip of the puncture element towards a tissue wall of the patient. In certain embodiments, the tissue-removal assemblyis connected to the energy sourceto provide shunting. For example, the tissue-removal assemblyincludes electrodes to receive electrical power from the energy sourceto deliver ablation energy to the target location (e.g., a target tissue) at a cardiovascular system (e.g., a circulatory system) wall. In certain embodiments, the handleis configured to be operated by a user to position the tissue-removal assemblyat the desired anatomical location. The catheter shaftgenerally defines a longitudinal axis of the shunting catheter. In some embodiments, the tissue-removal assemblymay be connected to a shunting shaft positioned within the catheter shaftat a first state (e.g., before a deployment and/or during a deployment to position the tissue-removal assembly). In certain embodiments, the shunting shaft has a pre-determined curve. In some examples, the shunting shaft has a pre-determined curve for the tissue-removal assembly to deploy. In certain embodiments, the shunting shaft is extended from the catheter shaftat a second state (e.g., a puncture state to puncture through a tissue wall of a patient) and/or a third state (e.g., a state to cut, remove, and/or collect an area of tissue).

106 118 106 118 According to certain embodiments, during deployment, the shunting deviceincluding the catheter shaftenters through a patient's CS ostium located in the patient's right atrium. The shunting devicemay then be oriented through one or more mechanisms in the patient's CS, as will be discussed in more details below. In some embodiments, in order to conform to the shape of the patient's CS, the catheter shaftis made of flexible materials that may bend according to the anatomy of the CS.

110 124 120 124 118 124 120 124 124 118 In certain embodiments, the shunting cathetercan include an optional apposition elementdisposed proximate to the tissue-removal assembly. In some embodiments, the apposition element is disposed within a shaft (e.g., an outer shaft) at the first state. In some embodiments, the apposition elementis protruded from the catheter shaftat the first state, the second state, and/or the third state. In certain embodiments, the apposition elementcan appose to a cardiovascular system wall (e.g., the front wall or back wall of the CS, a left atrium wall, a right atrium wall, etc.) at the second state and/or third state, for example, to help position and/or stabilize the tissue-removal assembly. In certain embodiments, the apposition elementincludes a braid structure. In some embodiment, the apposition elementmay include a nitinol braid that can be held within the catheter shaft.

112 104 104 1 FIG. According to some embodiments, various components (e.g., the controller) of the shunting catheter systemcan be implemented on one or more computing devices. A computing device may include any type of computing device suitable for implementing embodiments of the disclosure. Examples of computing devices include specialized computing devices or general-purpose computing devices such as workstations, servers, laptops, portable devices, desktop, tablet computers, hand-held devices, general-purpose graphics processing units (GPGPUs), and the like, all of which are contemplated within the scope ofwith reference to various components of the shunting catheter system.

112 112 110 In some embodiments, a computing device (e.g., the controller) includes a bus that, directly and/or indirectly, couples the following devices: a processor, a memory, an input/output (I/O) port, an I/O component, and a power supply. Any number of additional components, different components, and/or combinations of components may also be included in the computing device. The bus represents what may be one or more busses (such as, for example, an address bus, data bus, or combination thereof). Similarly, in some embodiments, the computing device may include a number of processors, a number of memory components, a number of I/O ports, a number of I/O components, and/or a number of power supplies. Additionally, any number of these components, or combinations thereof, may be distributed and/or duplicated across a number of computing devices. In some embodiments, various components or parts of components (e.g., controller, shunting catheter, etc.) can be integrated into a physical device.

104 112 In some embodiments, the shunting catheter systemincludes one or more memories (not illustrated). The one or more memories includes computer-readable media in the form of volatile and/or nonvolatile memory, transitory and/or non-transitory storage media and may be removable, nonremovable, or a combination thereof. Media examples include Random Access Memory (RAM); Read Only Memory (ROM); Electronically Erasable Programmable Read Only Memory (EEPROM); flash memory; optical or holographic media; magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices; data transmissions; and/or any other medium that can be used to store information and can be accessed by a computing device such as, for example, quantum state memory, and/or the like. In some embodiments, the one or more memories store computer-executable instructions for causing a processor (e.g., the controller) to implement aspects of embodiments of system components discussed herein and/or to perform aspects of embodiments of methods and procedures discussed herein.

Computer-executable instructions may include, for example, computer code, machine-useable instructions, and the like such as, for example, program components capable of being executed by one or more processors associated with a computing device. Program components may be programmed using any number of different programming environments, including various languages, development kits, frameworks, and/or the like. Some or all of the functionality contemplated herein may also, or alternatively, be implemented in hardware and/or firmware.

In some embodiments, the memory may include a data repository which may be implemented using any one of the configurations described below. A data repository may include random access memories, flat files, XML files, and/or one or more database management systems (DBMS) executing on one or more database servers or a data center. A database management system may be a relational (RDBMS), hierarchical (HDBMS), multidimensional (MDBMS), object oriented (ODBMS or OODBMS) or object relational (ORDBMS) database management system, and the like. The data repository may be, for example, a single relational database. In some cases, the data repository may include a plurality of databases that can exchange and aggregate data by a data integration process or software application. In an exemplary embodiment, at least part of the data repository may be hosted in a cloud data center. In some cases, a data repository may be hosted on a single computer, a server, a storage device, a cloud server, or the like. In some other cases, a data repository may be hosted on a series of networked computers, servers, or devices. In some cases, a data repository may be hosted on tiers of data storage devices including local, regional, and central.

104 Various components of the shunting catheter systemcan communicate via or be coupled to via a communication interface, for example, a wired or wireless interface. The communication interface includes, but is not limited to, any wired or wireless short-range and long-range communication interfaces. The wired interface can use cables, umbilicals, and the like. The short-range communication interfaces may be, for example, local area network (LAN), interfaces conforming to known communications standards, such as Bluetooth™ standard, IEEE 802 standards (e.g., IEEE 802.11), or other public or proprietary wireless protocol. The long-range communication interfaces may be, for example, wide area network (WAN), cellular network interfaces, satellite communication interfaces, etc. The communication interface may be either within a private computer network, such as intranet, or on a public computer network, such as the internet. Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, while the embodiments described above refer to particular features, the scope of this invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.

2 FIG. 2 FIG. 200 200 202 20 21 202 204 208 206 204 205 207 205 204 205 204 205 204 205 204 is a schematic diagram illustrating an example of a shunting deviceto be deployed in a heart of a patient, in accordance with embodiments of the present disclosure.is merely an example. One of the ordinary skilled in the art would recognize many variations, alternatives, and modifications. As shown, the shunting deviceincludes a shunting catheterto be delivered through a patient's coronary sinus (CS)via the CS ostium. In some embodiments, the shunting catheterincludes a catheter shaft, an optional apposition element, and a tissue-removal assembly. In certain embodiments, the catheter shaftreceives a shunting shaftwhich has a curve when extends out of a shaft opening. In some embodiments, as illustrated, the shunting shaftis extended from the catheter shaftat a second state (e.g., a puncturing state) and/or a third state (e.g., a state to cut, remove, and/or collect an area of tissue). In certain examples, the shunting shaftforms an angle greater than 30 degrees from a longitudinal axis of the catheter shaft. In some embodiments, the shunting shaftforms an angle proximate to 90 degrees from the catheter shaft. In some embodiments, the shunting shaftforms an angle in the range of 60 degrees to 120 degrees from the catheter shaft.

206 204 206 214 214 In some embodiments, the tissue-removal assemblyis extended from the catheter shaftat a second state (e.g., a state to puncture a tissue wall and/or remove an area of tissue from the tissue wall). According to some embodiments, the tissue-removal assemblyincludes a puncture elementhaving a tip defining a distal point of the puncture elementand a blade section. In some embodiments, the blade section of the puncture element has a tapered shape and includes a blade edge.

214 206 In some embodiments, the puncture elementof the tissue-removal assemblymay be configured to deliver energy, or include one or more electrodes configured to deliver energy (e.g., ablative energy, radiofrequency (RF) energy, phased RF energy, thermal energy, cryogenic energy, pulse ablative energy, (e.g., pulsed field ablation (PFA)), microwave energy, laser energy, ultrasound energy, etc.) to target tissue (e.g., a tissue wall of a patient).

204 20 204 204 207 204 204 204 204 In some embodiments, the catheter shaftis made of flexible material that may curve with the anatomy of the patient's CS. In certain embodiments, for example, the catheter shaftmay include polyether block amide, nylon, silicone, or a combination thereof. In some embodiments, the catheter shaftcan include a laser cut hypotube (LCHT) that may have a specific cut pattern to allow formation of the shaft opening. In some instances, the catheter shaftmay be a multi-layered and multi-material component. In some examples, the catheter shaftis reinforced with a braid and can have an etched or casted liner. The braid for reinforcing the catheter shaftmay be made of, for example, stainless steel, nitinol, rigid plastics, and the like. The liner may be made from polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE), copolymers of polyamide and polyether, polyether block amid (PEBAX), or a combination thereof. In some embodiments, the catheter shaftis coated for lubricity with a hydrophilic coating, or other types of coating suitable for coating a catheter shaft as known by a skilled person in the art.

202 202 202 In some embodiments, the shunting catheterhas a diameter of from about 2 mm to about 8 mm. In certain embodiments, the shunting catheterhas a diameter of from about 3 mm to about 7 mm. In some embodiments, the shunting catheter has a diameter of from about 4 mm to about 6 mm. In certain embodiments, the shunting cathetermay have a diameter allowing it to pass through vessels and parts of the cardiovascular system to reach a target location.

3 FIG. 3 FIG. 2 FIG. 300 308 300 300 302 20 302 308 304 306 314 is a schematic diagram of a side view of an example of a shunting deviceand a perspective view of an optional apposition elementof the shunting device, in accordance with embodiments of the present disclosure.is merely an example. One of the ordinary skilled in the art would recognize many variations, alternatives, and modifications. As shown, in some embodiments, the shunting deviceincludes a shunting catheterto be delivered through a patient's coronary sinus (CS) (e.g., the CSof). In certain embodiments, the shunting catheterincludes an apposition element, a catheter shaft, and a tissue-removal assemblyincluding a puncture component.

304 304 304 304 304 304 304 304 304 304 304 304 a b According to certain embodiments, the catheter shafthas a distal end, a proximal end (not shown), and a shaft lumen. In some embodiments, the catheter shaftis made of flexible material that may curve with the anatomy of the patient's CS. In certain embodiments, the catheter shaftmay include polyether block amide, nylon, silicone, and/or a combination thereof. In some instances, the catheter shaftmay be a multi-layered and multi-material component. In some examples, the catheter shaftis reinforced with a braid and can have an etched or casted liner, and/or a laser cut hypotube (LCHT). The braid for reinforcing the catheter shaftmay be made of stainless steel, nitinol, rigid plastics, and the like. The liner may be made from polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE), copolymers of polyamide and polyether, or a combination thereof. In certain embodiments, the catheter shaftmay be injection molded or extruded. In some embodiments, the catheter shaftcan include a laminated structure formed of multiple layers including, for example, a liner, a reinforcement braid or LCHT, and extrusions melted together. In some embodiments, the catheter shaftis coated for lubricity with a hydrophilic coating, or other types of coating suitable for coating a catheter shaft as known by a skilled person in the art. In some instances, the catheter shaftmay have multiple lumens.

304 305 304 305 304 305 304 305 304 a According to some embodiments, the catheter shaftmay include a stabilizing element such as distal tipat the distal endthat has a curve (e.g., a pre-existing curve), for example, a curve conforming to the anatomy of a patient's CS. In some instances, the distal tipmay be made of a different material than other parts of the catheter shaft. In some instances, for example, the distal tipmay be made of a material more flexible than the material of other parts of the catheter shaft. The distal tipmay be injection molded or machined to have a unique geometry (e.g., a curve) for better stabilizing the catheter shaftduring deployment.

305 304 304 304 304 304 307 306 309 309 307 c c a According to some embodiments, the distal tipmay have a length of from about 5 mm to about 85 mm. In certain embodiments, the catheter shaftincludes a shaft opening. In some embodiments, a portion of the catheter shaft from the shaft openingand the distal endhas a curve. In some embodiments, the catheter shaftdefines a first axis, and the tissue-removal assemblydefines a second axisat the second state after deployment. In certain embodiments, the second axisand the first axisform an angle greater than zero degree.

306 304 306 306 310 304 304 310 310 306 304 304 b b b According to certain embodiments, the tissue-removal assemblyis disposed in the shaft lumenat a first state (e.g., before a deployment and/or during a deployment to position the tissue-removal assembly). In certain embodiments, the tissue-removal assemblycan be connected to a shunting shaftpositioned within the shaft lumenof the catheter shaftat a first state. In certain embodiments, the shunting shafthas a pre-determined curve. In some examples, the shunting shafthas a pre-determined curve for the tissue-removal assemblyto deploy. In certain embodiments, the shunting shaft is extended from the shaft lumenof the catheter shaftat a second state (e.g., a puncturing state to puncture through a tissue wall of a patient) and/or a third state (e.g., a state to cut, remove, and/or collect an area of tissue).

312 304 312 306 312 312 312 314 In some embodiments, an optional expandable elementmay be coupled to the catheter shaft. The expandable elementmay be a balloon or a basket configured to be expanded when the tissue-removal assemblyis at a third state (e.g., a state to cut, remove, and/or collect an area of tissue). The expandable elementcan include a cutting component configured to cut an area of tissue from a tissue wall. In some embodiments, the cutting component can include ablation electrode(s) to deliver ablative energy. In some embodiments, the cutting component can include a mechanical coring edge (e.g., a cutting sheet). In some embodiments, the expandable elementcan be expanded to form a basket structure adjacent to the cutting component thereof. The cutting component can be positioned between the expandable componentand the puncture component.

314 304 314 306 304 304 306 b b According to certain embodiments, the puncture componentis disposed in the shaft lumenat a first state. The puncture componentmay be connected to the tissue-removal assemblypositioned within the shaft lumenof the catheter shaftat a first state (e.g., before a deployment and/or during a deployment to position the tissue-removal assembly).

314 306 304 314 312 9 FIG.B In some embodiments, the puncture component(e.g., along with the tissue-removal assembly) is extended from the catheter shaftat a second state (e.g., a puncturing state to puncture through a tissue wall). According to some embodiments, the puncture componentincludes a puncture element having a tip defining a distal point of the puncture element and a blade section. In some embodiments, the blade section of the puncture element has a tapered shape and includes a blade edge. For example, the blade section has a distal end at the blade edge and a proximal end close to the expandable element, with the blade section at the proximal end having a first thickness and the blade section at the distal end having a second thickness, where the second thickness is smaller than the first thickness. In some embodiments, a distal end of the blade edge is the tip of the puncture element. In certain embodiments, the blade section includes two flat surfaces, where the intersection of the two flat surfaces defines the blade edge, and a curved surface surrounding the two flat surfaces (see e.g.,).

314 In some embodiments, the puncture element of the puncture componentmay be configured to deliver energy, or include one or more electrodes configured to deliver energy (e.g., ablative energy, radiofrequency (RF) energy, phased RF energy, thermal energy, cryogenic energy, pulse ablative energy, (e.g., pulsed field ablation (PFA)), microwave energy, laser energy, ultrasound energy, etc.) to target tissue (e.g., a tissue wall of a patient).

314 314 304 314 304 314 304 304 314 314 314 314 314 b In certain embodiments, the puncture componenthas a pre-determined curve. In some embodiments, the puncture componentmay form an angle proximate to 90 degrees from the catheter shaft. In some embodiments, the puncture componentmay form an angle in the range of 60 degrees to 120 degrees from the catheter shaft. In certain embodiments, the puncture componentis extended from the shaft lumenof the catheter shaftat a second state (e.g., a puncturing state to use the puncture element on a distal end of the puncture component). In some examples, the puncture componentmay include one or more electrodes configured to deliver ablative energy when the puncture componentis at a second state. In certain examples, the puncture componentmay include a puncture element made of conductive material and configured to deliver ablative energy when the puncture componentis at a second state.

302 316 304 316 316 316 316 304 316 304 According to some embodiments, the shunting catheterfurther includes an outer shaftdisposed outside of at least a part of the catheter shaftduring deployment. In some embodiments, the outer shaftis made of flexible material that may curve with the anatomy of the patient's CS. In certain embodiments, for example, the outer shaftmay include polyether block amide, nylon, silicone, or a combination thereof. In some instances, the outer shaftmay be a multi-layered and multi-material component. In some examples, the outer shaftis reinforced with a braid and/or can have an etched or casted liner. The braid for reinforcing the catheter shaftmay be made of stainless steel, nitinol, rigid plastics, and the like. The liner may be made from polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE), copolymers of polyamide and polyether, or a combination thereof. In certain embodiments, the outer shaftmay be injection molded or extruded. In some embodiments, the catheter shaftis coated for lubricity with a hydrophilic coating, or other types of coating suitable for coating a catheter shaft as known by a skilled person in the art.

308 316 308 304 308 316 304 308 306 304 308 308 304 c According to certain embodiments, the apposition elementis disposed within the outer shaftat a first state (e.g., during deployment). In embodiments, the apposition elementprotrudes from the catheter shaftduring deployment. The apposition elementis flexible and compressed to fit within the outer shaftand configured to decompress and protrude from the catheter shaftduring deployment. In some embodiments, the apposition elementis disposed proximate to the tissue-removal assemblyand/or the one or more shaft openings. In some instances, the apposition elementis a braided structure including one or more metal wires such as, for example, nitinol wires, stainless steel wires, and the like. In yet some instances, the apposition elementis made of a flexible material having a portion protruding from the catheter shaft. In some examples, the flexible material may be a foam. In some instances, the flexible material may be a balloon filled with a contrast solution that shows up under fluoroscopy. In yet some instances, the flexible material may be a polymer with a radiopaque marker added for visualization. The radiopaque marker may include tantalum, gold, or any radiopaque marker known by a skilled person in the art.

308 302 In certain embodiments, the optional apposition elementcan be configured to appose a patient's tissue wall (e.g., the vessel wall of a patient's CS or LA) such that the shunting catheteris stabilized in one position once deployed.

4 FIG. 400 402 5 400 403 404 401 404 1 is a schematic diagram of a cross-sectional view of an example of a shunting catheterand a side view of an example puncture elementforming an angle θwith respect to a tissue wall, in accordance with embodiments of the present disclosure. The shunting catheterincludes a catheter shafthaving a shaft lumen, and a tissue-removal assemblydisposed within the shaft lumenat a first state (e.g., during deployment).

401 406 414 404 In some embodiments, the tissue-removal assemblyincludes a cutting componentcoupled to a distal portion of a shunting shaftwhich is advanceable inside the shaft lumen.

414 403 401 414 402 402 5 5 5 In certain embodiments, a distal portion of the shunting shaftis extended from a side opening of the catheter shaftat a second state. The tissue-removal assemblymay include a dilator (not shown). The dilator may be connected to a puncture element shaft (extendable inside a lumen of the shunting shaft, not shown) on one end, and a puncture element(e.g., a needle) on the other end. In some embodiments, the puncture elementmay be configured to deliver energy, or include one or more electrodes configured to deliver energy (e.g., ablative energy, radiofrequency (RF) energy, phased RF energy, thermal energy, cryogenic energy, pulse ablative energy, (e.g., pulsed field ablation (PFA)), microwave energy, laser energy, ultrasound energy, etc.) to target tissue (e.g., a tissue wallof a patient) to facilitate puncturing through a tissue wall. In some embodiments, the dilator may be configured to deliver energy, or include one or more electrodes configured to deliver energy (e.g., ablative energy, radiofrequency (RF) energy, phased RF energy, thermal energy, cryogenic energy, pulse ablative energy, (e.g., pulsed field ablation (PFA)), microwave energy, laser energy, ultrasound energy, etc.) to target tissue (e.g., a tissue wallof a patient).

401 403 401 414 414 401 414 403 5 414 414 414 402 5 401 414 403 402 406 402 402 402 In some embodiments, the tissue-removal assemblyis positioned within the catheter shaftat a first state (e.g., before a deployment and/or during a deployment to position the tissue-removal assembly). In certain embodiments, a distal portion of the shunting shafthas a pre-determined curve. In some examples, the curved distal portion of the shunting shaftis directly adjacent or in close proximity with the tissue-removal assembly. In certain embodiments, the shunting shaftis extended from the catheter shaftat a second state (e.g., a puncturing state to puncture tissue wall). In certain embodiments, the shunting shaftmay not have a predetermined curve and can be made of an at least semi-malleable material that may allow a physician to manipulate the distal portion of the shunting shaftinto a curve. The curve of the shunting shaftmay facilitate directing the puncture elementtowards the tissue wallat the second state during a puncturing procedure and/or at a third state during a tissue-removal procedure. In certain embodiments, the tissue-removal assembly, including a distal portion of the shunting shaft, is extended from the catheter shaftat a second state (e.g., a puncturing state to use the puncture element) and/or a third state (e.g., a cutting state to use a cutting component). In certain embodiments, the puncture elementhas a predetermined curve. The curve of the puncture elementmay bias the puncture element(e.g., a tip thereof) towards the tissue wall of the patient at the second state or third state during a puncturing or tissue-removal procedure.

403 403 407 402 5 409 409 407 409 407 409 407 409 407 402 402 According to some embodiments, the catheter shaftincludes a shaft opening. In some embodiments, the catheter shaftdefines a first axis, and where the tip of the puncture elementcontacts a tissue walldefines a second axis. In certain embodiments, the second axisand the first axisform an angle greater than zero degrees. In certain examples, the second axisand the first axisform an angle greater than 30 degrees. In some embodiments, the second axisand the first axisform an angle proximate to 90 degrees. In some embodiments, the second axisand the first axisform an angle in the range, for example, from 60 degrees to 120 degrees. In some instances, the puncture elementincludes a pre-curve formed from a semi-rigid or rigid material. The semi-rigid or rigid material of the puncture elementmay include nitinol or stainless steel (SS) with a curve built in before deployment.

414 414 404 414 404 414 411 414 414 414 402 402 402 402 402 411 5 409 411 2 2 2 In some embodiments, the shunting shaftincludes a curved portion that forms an arc connecting a first straight portion of the shunting shaftdisposed inside the shaft lumenand a second straight portion of the shunting shaftextended outward from the shaft lumen, the second straight portion of the shunting shaftdefines an axis. In embodiments, for example as shown, the curved portion of the shunting shaftis adjacent a shaft opening. In certain embodiments, a dilator can be located at the end of the second straight portion of the shunting shaftand outside of the curved portion of the shunting shaft. In some embodiments, the puncture elementincludes a curve, thus having a concave shape on one side of the puncture element, and a convex shape on the other side of the puncture element. As shown, the curve of the puncture elementis configured to bias the tip of the puncture elementaway from the axisand towards the tissue wall. In certain embodiments, the axisand axisdefines an angle θ. In some embodiments, the angle θmay be above zero degrees and below 180 degrees. In some embodiments, the angle θmay be above zero degrees and below 90 degrees.

400 400 403 414 401 400 400 In certain embodiments, the shunting catheterincludes multiple compartments (e.g., lumens) for various elements to provide more targeted control during deployment. For example, the shunting cathetermay include an additional lumen in between the catheter shaftand the shunting shaftfor more precise control during deployment of the tissue-removal assembly. In some embodiments, the shunting cathetermay include lumens for containing functional components such as a guidewire or pull wire assembly. In yet some embodiments, the shunting cathetermay include additional lumens for holding shunted tissue from a tissue wall.

409 407 414 402 402 402 5 409 422 5 414 402 402 402 5 409 402 422 402 5 5 5 1 1 1 1 In some embodiments, the angle between the second axisand the first axismay be a result of the curve in shunting shaftand a curve of puncture element, where the curve of the puncture elementfurther biases the puncture elementtowards the tissue wall. Therefore, the angle θbetween the second axisand a third axisdefined by the tissue wallmay also result from the curve in shunting shaftand the curve of puncture element. When a puncture assembly is extended from a catheter shaft at a second state or a third state, the distance between an outer surface of the catheter shaft and a surface of a patient's tissue wall (e.g., an inner surface of the vessel wall of a patient) may be small enough that a crimp shaft is prevented from curving more than a certain amount. This may result in the angle θbeing greater than 90 degrees and preventing a tip of a puncture element from catching on, and puncturing through, the tissue wall at the intended target location. Instead, the tip of the puncture element may slide along the tissue wall before puncturing through, potentially damaging more of the tissue wall than intended and puncturing through the tissue wall at a different location than the target location. In some embodiments, the curved nature of puncture elementmay bias the tip of puncture elementtowards tissue wallsuch that the angle θbetween the second axis(defined by the tip of the puncture element) and the third axisis closer to 90 degrees. When the angle θis closer to 90 degrees, puncture elementmay more easily pierce through the tissue wall, preventing excess damage to the tissue wallfrom dragging, and puncturing the tissue wallmore accurately at the target location.

401 414 414 401 414 402 403 In some embodiments, the tissue-removal assemblyincludes a tube (e.g., a hypotube) to support the shunting shaft. The tube may include a plurality of laser cuts generally perpendicular to longitudinal axis defined by shunting shaft. In some embodiments, the tube may be formed of a conductive material configured to transmit energy to one or more electrodes on the tissue-removal assemblyto transmit energy to puncture tissue of a patient. In some instances, the tube can be made of stainless steel or nitinol. In certain instances, the tube may further include a pull wire assembly to control the flex or angle of the shunting shaftand/or the puncture elementrelative to the catheter shaft. The pull wire assembly may be laser welded to the tube or inside the tube at a distal end of the tube. In some embodiments, the pull wire assembly may include nitinol, stainless steel (SS), cobalt, chromium, titanium, or a combination thereof.

414 401 402 5 414 414 402 5 The shunting shaftmay be made of a semi-rigid or rigid material to have a pre-formed angle before deployment. After the tissue-removal assemblyis deployed, the pre-formed angle may be further adjusted using the pull wire assembly to further adjust and/or stabilize the contact point between the puncture elementand the tissue wall. In some embodiments, the shunting shaftmay be made of a semi-malleable material, where the curve in the shunting shaftis formed in response to manipulation of the pull wire to adjust and/or stabilize the contact point between the puncture elementand the tissue wall.

400 400 In certain embodiments, during deployment, the guidewire may be used to guide the shunting catheterinto the CS of a patient. In yet certain embodiments, the guidewire may be used to indicate the location of the shunting catheter including one or more of the components (e.g., the puncture assembly, the shaft opening of the shunting catheter, etc.) in the CS of a patient.

5 FIG.A 5 5 FIGS.B-D 5 FIG.A 500 520 500 5 520 500 510 512 510 514 515 514 520 522 524 515 510 520 524 522 514 520 524 522 515 510 is a schematic diagram illustrating an example of a shunting catheterincluding a tissue-removal assembly, in accordance with some embodiments of the present disclosure.are schematic diagrams of side views of the shunting catheterofwhich is deployed to create a shunt in a tissue wallutilizing the tissue-removal assembly. According to some embodiments, the shunting catheterincludes a catheter shafthaving a distal endand a proximal end (not shown). The catheter shaftincludes a shaft lumenand a side openingin communication with the shaft lumen. The tissue-removal assemblyincludes a shunting shafthaving a distal portionbeing extendable from the side openingof the catheter shaft. Before the tissue-removal assemblyis deployed for tissue removal, the distal portionof the shunting shaftis received inside the shaft lumenat a first state. When the tissue-removal assemblyis deployed for tissue removal, the distal portionof the shunting shaftcan extend from the side openingof the catheter shaftto form a curved shape with a first curvature.

524 522 524 522 522 524 524 524 524 515 510 524 510 524 522 In some embodiments, the distal portionof the shunting shaftis formed of nitinol. It is to be understood that the distal portionof the shunting shaftcan be formed of any suitable material (e.g., stainless steel, platinum iridium, thermoplastic, PEEK, and the like) configured to be self-bending/bendable to form a curved shape. For example, in some embodiments, the shunting shaftcan be formed of stainless steel, platinum iridium, thermoplastic, PEEK, and the like. The distal portioncan be shape-set so that the distal portiontends to self-bend into a curved shape when the distal portionis unconstrained, such as when the distal portionextends out from the side openingof the catheter shaft. Prior to extension, the distal portionmay be maintained in a less curved shaped. In some embodiments, the catheter shafthas a sufficiently resilient body to resist deformation due to the shape-set, self-bending property of the distal portionof the shunting shaft.

5 FIG.B 520 525 524 522 525 524 525 525 525 As shown in, the tissue-removal assemblyincludes a cutting componentcoupled to the distal portionof the shunting shaft. The cutting componenthas a ring shape, is disposed on an edge of the distal portionand configured to cut and/or remove an area of tissue from a tissue wall (e.g., the vessel wall of a patient's CS). In some embodiments, the cutting componentcan include an ablation electrode to deliver a radiofrequency (RF) ablation on the tissue in contact. In some embodiments, the cutting componentcan include a mechanical cutting member, for example, a sharp cutting edge to cut the tissue in contact to the cutting component.

5 FIG.B 5 FIG.B 5 FIG.C 520 530 524 522 532 530 524 522 532 530 532 524 522 532 522 530 525 As shown in, the tissue-removal assemblyfurther includes a puncture elementbeing extendable from the distal portionof the shunting shaft. A puncture element shaftmovably connects the puncture elementto the distal portionof the shunting shaft. The puncture element shaftis configured to move the puncture elementbetween an extended state (e.g.,) and a retracted state (e.g.,). At the retracted state, the puncture element shaftis at least partially received inside a lumen of the distal portionof the shunting shaft. At the extended state, the puncture element shaftextends out of the lumen of the shunting shaftsuch that the puncture elementmoves away from the cutting component.

5 FIG.B 530 534 531 530 534 530 530 524 522 524 522 510 510 530 510 510 1 2 2 1 a a As shown in, the puncture elementfurther includes a puncture tipat a distal pointof the puncture element. The puncture tipcan include an electrode to deliver a radiofrequency (RF) ablation or a mechanical puncturing tip. In some embodiments, the puncture elementhas a curved cone shape with a second curvature. In some embodiments, the second curvature of the puncture elementcan have the same sign of the first curvature of the distal portionof the shunting shaft. For example, the distal portionof the shunting shaftmay be curved to form a first angle θwith respect to the axisof the catheter shaft, and the puncture elementmay be further curved to form a second angle θwith respect to the axisof the catheter shaft. The second angle θcan be greater than the first angle θ.

5 FIG.B 530 536 530 536 530 530 536 530 536 As shown in, the puncture elementfurther includes an array of tissue capturing structurescoupled to the puncture element. In some embodiments, the tissue capturing elementscan be part of the puncture element. For example, the puncture elementwith the tissue capturing structurescan be formed by machining into a solid material body as a one-piece structure. In some embodiments, the puncture elementand the tissue capturing structurescan be formed separately and then coupled with each other by, e.g., welding or bonding.

6 FIG.A 5 FIG.B 5 FIG.C 6 FIG.A 6 FIG.A 530 532 536 530 536 57 530 59 530 524 522 536 53 530 illustrates an enlarged side view of the puncture elementconnecting to the puncture element shaft. The array of tissue capturing structuresis configured to capture an area of tissue from the tissue wall when the puncture elementis retracted from the extended state () to the retracted state (). As shown in the embodiment depicted in, each of tissue capturing structuresincludes a first enddisposed on a surface of the puncture elementand a second end or tipprojecting from the puncture elementtoward the distal portionof the shunting shaft. In the embodiment depicted in, the array of tissue capturing structuresis disposed on a rear surfaceof the puncture element.

520 514 510 522 514 510 520 524 515 510 530 5 532 530 5 532 536 52 5 53 536 525 52 525 5 52 5 526 522 522 522 514 510 52 5 52 5 5 FIG.B 5 FIG.C 5 FIG.D In some embodiments, the tissue-removal assemblyis deployed in the shaft lumenof the catheter shaftat a first state. For example, the shunting shaftis received and advanced inside the shaft lumenof the catheter shaft. The tissue-removal assemblycan be operated to a second state, where the distal portionof the shunting shaft extends from the side openingof the catheter shaftto form a curved shape with a first curvature. When the puncture elementapproaches the tissue wall, the puncture element shaftcan extend to move the puncture elementfrom the retracted state to the extended state to puncture through tissue wall, as illustrated in. The puncture element shaftcan then be retracted such that the tissue capturing structuresgrab an area of tissuefrom the tissue wall, as shown in. The rear surfaceand/or the tissue capturing structurescan engage the cutting componentsuch that a periphery of the area of tissuein contact to the cutting componentcan be cut from the tissue wall, as shown in. The area of tissuecut from the tissue wallcan be received and collected inside the openingof the shunting shaftand removed along with the shunting shaftwhen the shunting shaftis retraced into the shaft lumenof the catheter shaft. After the area of tissueis removed from the tissue wall, an opening′ is formed in the tissue wall.

6 FIG.B 7 FIG.B 7 FIG.A 7 FIG.B 7 FIG.B 7 FIG.C 530 536 53 530 525 530 526 522 530 5 532 530 526 5 532 536 52 5 526 524 52 536 536 536 526 525 52 5 525 52 52 5 526 522 522 522 514 510 52 5 52 5 In some embodiments, a puncture element described herein can have various configurations to puncture a tissue wall when the shunting shaft is extended and to capture an area of tissue from the tissue wall when the shunting shaft is retracted. For example, in the embodiment depicted in, the puncture element′ has a cone shape and includes an array of tissue capturing structures′ each being a sharp projection projecting from a conical surface′ of the puncture element′toward the cutting component. The puncture element′ can be completely received inside the openingof the shunting shaft(e.g., as illustrated in). As shown in, when the puncture element′ approaches the tissue wall, the puncture element shaftcan extend to move the puncture element′ out of the openingto puncture through the tissue wall. The puncture element shaftcan then be retracted such that the tissue capturing structures′ grab an area of tissuefrom the tissue wallinto the openingof the distal portionof the area of tissue, as shown in. The tissue capturing structures′ can act as barbs to allow the tissue to stick onto the tissue capturing structures′. The tissue capturing structures′ can then drag the tissue into the openingsuch that the cutting componentcan cut the area of tissuefrom the tissue wall, as shown in. In some embodiments, the cutting componentcan include ablation electrode(s) to deliver ablative energy to cut/remove the area of tissue. The area of tissuecut from the tissue wallcan be received inside the openingof the shunting shaftand be removed along the shunting shaftwhen the shunting shaftis retraced into the shaft lumenof the catheter shaft. After the area of tissueis removed from the tissue wall, an opening′ is formed in the tissue wall, as shown in.

8 8 FIGS.A andB 8 FIG.C 8 8 FIGS.C andD 8 FIG.D 600 620 622 515 510 622 81 81 626 624 622 622 515 510 626 5 81 52 626 624 622 627 64 625 626 627 627 52 626 52 625 626 52 5 5 625 627 64 622 In some embodiments, a vacuum mechanism can fluidly connect to the distal portion of a shunting shaft to generate a reduced pressure at an opening of the distal portion of the shunting shaft. When the distal portion of the shunting shaft is deployed adjacent to or in contact to the issue wall, an area of tissue can be pulled by suction into the opening of the distal portion of the shunting shaft. As shown in the embodiment of, a shunting catheterincludes a tissue-removal assemblyincluding a shunting shaftextends out of the side openingof the catheter shaft. The shunting shaftcan have a lumen functionally connected to a vacuum mechanismat a proximal end thereof (not shown). The vacuum mechanismcan include, for example, a vacuum pump, to generate a reduced pressure at the openingof the distal portionof the shunting shaft. When the shunting shaftis deployed to extend out of the side openingof the catheter shaft, the openingapproaches and contacts the tissue wall. The vacuum mechanismcan be turned on to pull by suction an areaof tissue into the opening, as shown in. The distal portionof the shunting shaftincludes a retention feature(e.g., as illustrated in) disposed on a wall(e.g., an inner surface thereof). In some embodiments, a cutting membercan be provided at the opening, adjacent to the retention feature. In some embodiments, the retention featureis configured to retain the area of tissueinside the opening. With the tissuebeing retained in position, the cutting memberat the openingcan then cut and remove the area of tissuefrom the tissue wallto create an opening in the tissue wall. The cutting componentcan include ablation electrode(s) to deliver ablative energy. In some embodiments, the retention featurecan include an array of spikes arranged on the inner wallof the shunting shaft, as shown in.

9 9 FIGS.A-D 9 FIG.B 9 FIG.C 9 FIG.D 700 720 720 732 724 722 732 734 740 734 732 736 726 722 736 732 5 740 742 740 5 734 742 740 734 742 740 742 52 732 52 726 722 725 726 52 5 725 742 52 5 are schematic diagrams illustrating an example of a shunting catheterincluding a tissue-removal assembly, in accordance with some embodiments of the present disclosure. The tissue-removal assemblyincludes a puncture element shaftwhich is received inside a lumen of a distal portionof a shunting shaft. The puncture element shaftincludes a sheathand an elongate punching memberreceived inside the sheath. The puncture element shaftincludes a distal endbeing extendable out of an openingof the shunting shaft. When the distal endof the puncture element shaftapproaches to contact with or in close proximity to the tissue wall, the elongate punching membercan be extended such that the distal portionof the elongate punching membercan punch through the tissue wall(). The sheathcan then be retracted to expose the distal portionof the elongate punching memberout of the sheathsuch that each of the distal portionof the elongate punching membercan bend to form a hook shape (). In some embodiments, the distal portioncan include multiple nitinol wires or other shape-set configurations (e.g., a laser cut hypotube or LCHT), which can act as anchors to grab and retain an area of tissue. The puncture element shaftcan then be retracted to grab the area of tissueinto the openingof the shunting shaft. A cutting memberat the openingcan then cut the area of tissuefrom the tissue wall, as shown in. In some embodiments, the cutting componentand/or the distal portioncan include ablation electrode(s) to deliver ablative energy to facilitate the cutting of the tissuefrom the tissue wall.

10 10 FIGS.A-C 10 FIG.B 10 FIG.C 820 800 820 820 810 826 824 822 810 812 811 812 814 5 824 5 5 811 811 812 5 811 52 826 822 825 826 52 5 are schematic diagrams of an example of a tissue-removal assemblyutilizing a puncture element to create a shunt in a tissue wall, in accordance with embodiments of the present disclosure. As shown, a shunting catheterincludes the tissue-removal assembly. The tissue-removal assemblyincludes a helical anchorbeing extendable from an openingof the distal portionof the shunting shaft. The helical anchorincludes a helical portion, a shaftto support and rotate the helical portion, and a tipto puncture through the tissue wall. When the distal portionapproaches the tissue wallto contact with or be in close proximity to the tissue wall, the shaftcan be extended/rotated/twisted by an anchor driver connected to a remote end (not shown) of the shaftsuch that the helical portioncan screw into and punch through the tissue wall(). The shaftcan then be retracted to grab the area of tissueinto the openingof the shunting shaft. A cutting memberat the openingcan then cut the area of tissuefrom the tissue wall, as shown in.

11 11 FIGS.A-D 11 FIG.A 11 FIG.D 900 900 910 910 910 914 915 914 920 924 915 910 920 900 910 5 915 952 5 a are schematic diagrams of side views of an example of a shunting catheter, in accordance with embodiments of the present disclosure. In some embodiments, the shunting catheterincludes a catheter shaftextending along an axis. The catheter shaftincludes a shaft lumenand a side openingin communication with the shaft lumen. A shunting shafthas a distal portionbeing extendable from the side openingof the catheter shaft. In some embodiments, the shunting shaftcan be formed of a laser cut hypotube (LCHT). For example, the shunting catheteris first deployed to have the catheter shaftto be substantially parallel to the tissue walland to have the side openingto face the area of tissueto be removed from the tissue wall(e.g.,or).

924 920 914 915 924 92 923 925 5 910 901 951 914 910 920 952 93 952 5 952 952 11 11 FIGS.B andC 11 FIG.C 11 FIG.C In some embodiments, the distal portionof the shunting shaftreceived inside the shaft lumencan then extend out of the side opening. The distal portionincludes a shovel structurehaving one or more cutting bladesand a cutting edgeto cut through the tissue wall(e.g.,). The catheter shaftcan be moved along the directionsuch that an endof the cut tissue is directed into the shaft lumenof the catheter shaft(e.g.,). The shunting shaftcan then be pulled back, e.g., by a guidewire or pull wire, to have the shovel structure to cut an areaof tissue from the tissue wall. In some embodiments, the shovel structure can include a slicing memberextending from a base of the shovel structure to cut the areafrom the tissue wall(e.g.,). In some embodiments, the areaof tissue and the shunt′ can have a substantially oval shape instead of a circular shape.

12 FIG. 1 FIG. 1 FIG. 1000 104 112 is a flow diagram illustrating an example methodof creating a shunt in a patient, in accordance with embodiments of the present disclosure. The method is described in relation to the catheters discussed previously here, however, any suitable electroporation catheter can be used in the method. Aspects of embodiments of the method may be performed, for example, by a shunting catheter system or a controller (e.g., the systemin, the controllerin). One or more steps of method are optional and/or can be modified by one or more steps of other embodiments described herein. Additionally, one or more steps of other embodiments described herein may be added to the method. In some embodiments, the shunt may be formed in a coronary sinus of a patient. In certain embodiments, the shunt includes an opening between a patient's coronary sinus and left atrium.

1000 1010 According to certain embodiments, the methodincludes the processof deploying a tissue-removal assembly in a shaft lumen of a catheter shaft at a first state. The tissue-removal assembly includes a shunting shaft and a cutting component disposed at a distal end of the shunting shaft. In some embodiments, the cutting component includes an ablation electrode, and the cutting the tissue wall includes delivering ablation energy to a target location using the ablation electrode. In some embodiments, the cutting component includes a shovel structure extending from the distal end of the shunting shaft. In some embodiments, the cutting component further includes a slicing member extending from a base of the shovel structure.

1000 1020 According to some embodiments, the methodincludes the processof operating the tissue-removal assembly to a second state. The distal end of the shunting shaft extends from a side opening of the catheter shaft with a curved shape.

1000 In some embodiments, the methodfurther includes extending a puncture element from the distal end of the shunting shaft. In certain examples, a puncture element shaft movably connects the puncture element to the distal end of the shunting shaft, and is configured to move the puncture element between an extended state and a retracted state.

1000 In some embodiments, the methodfurther includes moving the puncture element to the extended state to puncture through the tissue wall. The puncture element further includes a puncturing tip at a distal portion thereof.

1000 In some embodiments, the puncture element shaft includes a sheath and a plurality of shape-memory wires received in the sheath. When the puncture element is at the extended state, the methodfurther includes retracting the sheath to expose a distal portion of the plurality of shape-memory wires to form a plurality of anchors.

1000 In some embodiments, the methodfurther includes extending a plurality of puncturing wires from the distal end of the shunting shaft to puncture through the tissue wall, forming a plurality of anchors at a distal portion of the plurality of puncturing wires, and retracting the plurality of anchors to grab the area of tissue into the distal end of the shunting shaft.

1000 In some embodiments, the methodfurther includes extending a helical anchor from the distal end of the shunting shaft to puncture through the area of tissue and retracting the helical anchor to grab the area of tissue into the distal end of the shunting shaft.

1000 In some embodiments, the methodfurther includes expanding the distal end of the shunting shaft to form a basket structure.

1000 1030 1000 1000 According to certain embodiments, the methodincludes the processof disposing the cutting component approximate to a tissue wall of a patient. In some embodiments, the methodfurther includes retracting the puncture element back to the retracted state. The puncture element further includes an array of tissue capturing structures to grab the area of tissue into the distal end of the shunting shaft. In some embodiments, the methodfurther includes grabbing the area of tissue into the distal end of the shunting shaft using the plurality of anchors when the puncture element is moved to the retracted state.

1000 In some embodiments, the methodfurther includes generating a reduced pressure at the distal end of the shunting shaft to pull the area of tissue into the distal end of the shunting shaft.

1000 1040 According to certain embodiments, the methodincludes the processof cutting, using the cutting component, the tissue wall.

1000 1050 According to some embodiments, the methodincludes the processof removing an area of tissue from the tissue wall to form a shunt (e.g., an opening, one or more openings) in the tissue wall using the tissue-removal assembly.

3 FIG. 312 In some embodiments, a hybrid process can be applied to create a shunt on a cardiovascular system wall in a patient. For example, a relatively small portion/area of tissue (e.g., having an outer diameter or width from 1 mm to 7 mm) can be removed from a tissue wall to create a first opening, using the shunting catheters and methods described herein. The first opening can have a first dimension (e.g., an outer diameter or width/length) from 1 mm to 7 mm. Expansion mechanisms can then be applied to expand the first opening to a second opening having a second dimension greater than the first dimension. The second dimension (e.g., an outer diameter or width/length) can be in the range from 3 mm to 15 mm. Example expansion mechanisms can include a balloon, a Niti frame, or other suitable expandable elements. For example,illustrates the expandable elementwhich may be a balloon, or a basket configured to expand the first opening to a target diameter. In some embodiments, after the first opening is created, an inner catheter including a tissue-removal assembly can be exchanged with another catheter including the expansion mechanism which can be deployed to expand the first opening to the target diameter.

According to some embodiments of the present disclosure, a shunting catheter includes a catheter shaft including a shaft lumen and a side opening, and a tissue-removal assembly disposed in the shaft lumen in a first state and including a shunting shaft being extendable from the side opening of the catheter shaft. The shunting shaft has a curved shape when extending from the side opening to a second state, and the shunting shaft has an opening at a distal end thereof. The tissue-removal assembly includes a cutting component disposed at the distal end of the shunting shaft.

In certain embodiments, the cutting component includes an ablation electrode or a mechanical cutting member.

In certain embodiments, the cutting component has a ring shape.

In certain embodiments, the tissue-removal assembly further includes a puncture element being extendable from the distal end of the shunting shaft, and a puncture element shaft movably connecting the puncture element to the distal end of the shunting shaft. The puncture element shaft is configured to move the puncture element between an extended state and a retracted state.

In certain embodiments, the puncture element further includes a puncturing tip at a distal portion thereof.

In certain embodiments, the puncturing tip includes an electrode to deliver a radiofrequency (RF) ablation or a mechanical puncturing tip.

In certain embodiments, the puncture element has a curved cone shape.

In certain embodiments, the puncture element further includes an array of tissue capturing structures, each tissue capturing structure of the array of tissue capturing structures having a first end disposed at a surface of the puncture element and a second end extended from the surface of the puncture element.

In certain embodiments, the puncture element shaft includes a sheath and an elongate puncturing member received in the sheath, and the elongate puncturing member is extendable from the sheath to form an anchor.

In certain embodiments, the puncture element is a curved puncture element including a curved body and a tip, the tip of the curved puncture element extending along a first axis and the curved body extending along a second axis, wherein the first axis and the second axis form an angle greater than zero degrees.

In certain embodiments, the tissue-removal assembly includes a plurality of puncturing wires extendable from the distal end of the shunting shaft, a distal portion of the plurality of puncturing wires being configured to form a plurality of anchors.

In certain embodiments, the tissue-removal assembly includes a helical anchor being extendable from the distal end of the shunting shaft.

In certain embodiments, the distal end of the shunting shaft further includes an expandable basket structure adjacent to the cutting component.

In certain embodiments, the cutting component includes a shovel structure extending from the distal end of the shunting shaft.

In certain embodiments, the cutting component further includes a slicing member extending from a base of the shovel structure.

In certain embodiments, the shunting catheter further includes a vacuum mechanism fluidly connected to the opening at the distal end of the shunting shaft to generate a reduced pressure at the opening.

In certain embodiments, the distal end of the shunting shaft includes a retention feature disposed on an inner wall of the distal end adjacent to the cutting component.

According to certain embodiments of the present disclosure, a method of creating a shunt includes deploying a tissue-removal assembly in a shaft lumen of a catheter shaft at a first state, the tissue-removal assembly including a shunting shaft and a cutting component disposed at a distal end of the shunting shaft, operating the tissue-removal assembly to a second state, wherein the distal end of the shunting shaft extends from a side opening of the catheter shaft with a curved shape, disposing the cutting component approximate to a tissue wall of a patient, cutting, using the cutting component, the tissue wall, and removing an area of tissue from the tissue wall to form an opening in the tissue wall using the tissue-removal assembly.

In certain embodiments, the cutting component includes an ablation electrode, and the cutting of the tissue wall includes delivering ablation energy to a target location using the ablation electrode.

In certain embodiments, the method further includes extending a puncture element from the distal end of the shunting shaft. A puncture element shaft movably connects the puncture element to the distal end of the shunting shaft and is configured to move the puncture element between an extended state and a retracted state.

In certain embodiments, the method further includes moving the puncture element to the extended state to puncture through the tissue wall. The puncture element further includes a puncturing tip at a distal portion thereof.

In certain embodiments, the method further includes retracting the puncture element back to the retracted state. The puncture element further includes an array of tissue capturing structures to grab the area of tissue into an opening at the distal end of the shunting shaft.

In certain embodiments, the puncture element shaft includes a sheath and an elongate puncturing member received in the sheath, and when the puncture element is at the extended state, exposing a distal portion of the elongate puncturing member to form an anchor.

In certain embodiments, the method further includes grabbing the area of tissue into an opening at the distal end of the shunting shaft using the anchor when the puncture element is moved to the retracted state.

In certain embodiments, the method further includes extending an elongate puncturing member from the distal end of the shunting shaft to puncture through the tissue wall, forming an anchor at a distal portion of the elongate puncturing member, and retracting the anchor to grab the area of tissue into an opening at the distal end of the shunting shaft.

In certain embodiments, the method further includes extending a helical anchor from the distal end of the shunting shaft to puncture through the area of tissue and retracting the helical anchor to grab the area of tissue into an opening at the distal end of the shunting shaft.

In certain embodiments, the method further includes expanding the distal end of the shunting shaft to form a basket structure adjacent to the cutting component.

In certain embodiments, the cutting component includes a shovel structure extending from the distal end of the shunting shaft.

In certain embodiments, the cutting component further includes a slicing component extending from a base of the shovel structure.

In certain embodiments, the method further includes generating a reduced pressure at an opening at the distal end of the shunting shaft to pull the area of tissue into the opening.

Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present disclosure. For example, while the embodiments described above refer to particular features, the scope of this invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.